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特拉唑嗪。对其用于良性前列腺增生症的药物经济学评价。

Terazosin. A pharmacoeconomic evaluation of its use in benign prostatic hyperplasia.

作者信息

Plosker G L, Goa K L

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Pharmacoeconomics. 1997 Feb;11(2):184-97. doi: 10.2165/00019053-199711020-00008.

DOI:10.2165/00019053-199711020-00008
PMID:10165827
Abstract

Benign prostatic hyperplasia (BPH) is a common disorder in elderly men which carries a substantial economic burden. Urinary symptoms associated with moderate to severe disease can significantly interfere with daily activities and reduce quality of life. Obstruction of urine flow in men with BPH can result from nonmalignant enlargement of the prostate gland (static component of BPH) and from alpha 1 receptor-mediated increased smooth muscle tone of the bladder neck and prostate (dynamic component of BPH). Transurethral resection of the prostate (TURP) is generally very effective and has traditionally been the standard treatment for men with moderate to severe BPH. However, response to therapy with TURP is not universal and the procedure is associated with a number of potential complications. Moreover, many men prefer to avoid or are not suitable candidates for this invasive procedure. Thus, there is an increasing role for less invasive treatment, including drug therapy, in men with moderate to severe BPH. Terazosin is an alpha 1 receptor antagonist which has been shown in placebo-controlled trials to significantly improve American Urology Association (AUA) symptom and quality-of-life scores and symptom problem index ('bother' score), as well as increase peak urinary flow rate, in men with BPH. In a recent large randomised US trial, treatment for 1 year with terazosin titrated to 10 mg/day improved mean AUA symptom score and peak urinary flow rate to a significantly greater extent than finasteride 5 mg/day in men with moderate to severe BPH. The most frequently reported adverse events associated with terazosin include dizziness, asthenia, postural hypotension, somnolence, headache, peripheral oedema, nasal congestion/rhinitis and syncope. Approximately 5% of men with BPH discontinue terazosin because of adverse events. Results of an economic evaluation of terazosin, in which both clinical and economic data were collected prospectively in a randomised placebo-controlled study design, showed similar total direct treatment costs per 1000 patients associated with 1 year of therapy with terazosin ($US3.57 million) and placebo ($US3.78 million) in men with moderate to severe BPH (1992 dollars). The analysis, which was conducted from the perspective of a managed care organisation in the US, demonstrated that the lower medication costs in the placebo group relative to the terazosin group were offset by increased inpatient care costs. Thus, terazosin (titrated to response up to a maximum of 10 mg/day) was significantly more effective than placebo in improving disease-specific symptoms and quality of life, but at a similar overall cost to placebo. Another economic analysis, also conducted from a third-party payer perspective in the US, modelled direct treatment costs associated with terazosin, finasteride and TURP during the first 2 years after initiating therapy in men with moderate to severe BPH. Results of the study favoured terazosin; the private insurance cost per patient undergoing primary treatment with TURP was $US6411, compared with $US2860 with finasteride (45% of the cost of TURP) and $US2422 with terazosin (38% of the cost of TURP). Medicare costs were lower for all 3 treatment groups but the relative comparisons were similar; corresponding costs per patient were $US3874, $US2161 and $US1820 (1992 dollars). A companion break-even cost analysis used a hypothetical cohort of men with BPH starting treatment at age 67 years. Private insurance costs associated with terazosin remained lower then those associated with TURP for approximately 15 years (the corresponding break-even point was 10 years for finasteride vs TRUP). Medicare costs associated with terazosin would not exceed those of TURP for approximately 7 years (5.5 years for finasteride vs TURP). In conclusion, a limited number of detailed pharmacoeconomic analysis of terazosin have been conducted to date, although it has not been compared with other a1 receptor antagonists.

摘要

良性前列腺增生(BPH)是老年男性的常见疾病,带来了巨大的经济负担。与中重度疾病相关的泌尿系统症状会严重干扰日常活动并降低生活质量。BPH男性患者的尿流梗阻可能源于前列腺的非恶性肿大(BPH的静态成分)以及α1受体介导的膀胱颈和前列腺平滑肌张力增加(BPH的动态成分)。经尿道前列腺切除术(TURP)通常非常有效,传统上一直是中重度BPH男性患者的标准治疗方法。然而,TURP治疗的反应并不普遍,且该手术存在一些潜在并发症。此外,许多男性更愿意避免或不适合接受这种侵入性手术。因此,对于中重度BPH男性患者,包括药物治疗在内的侵入性较小的治疗方法的作用越来越大。特拉唑嗪是一种α1受体拮抗剂,在安慰剂对照试验中已表明,它能显著改善美国泌尿外科学会(AUA)症状评分和生活质量评分以及症状问题指数(“困扰”评分),还能提高BPH男性患者的最大尿流率。在最近一项美国大型随机试验中,对于中重度BPH男性患者,将特拉唑嗪滴定至10mg/天治疗1年,其平均AUA症状评分和最大尿流率的改善程度明显大于非那雄胺5mg/天。与特拉唑嗪相关的最常报告的不良事件包括头晕、乏力、体位性低血压、嗜睡、头痛、外周水肿、鼻充血/鼻炎和晕厥。约5%的BPH男性患者因不良事件停用特拉唑嗪。一项对特拉唑嗪的经济学评估结果显示,在一项随机安慰剂对照研究设计中前瞻性收集临床和经济数据,中重度BPH男性患者接受1年特拉唑嗪治疗(357万美元)和安慰剂治疗(378万美元),每1000名患者的总直接治疗成本相似(1992年美元)。该分析是从美国一家管理式医疗组织的角度进行的,结果表明安慰剂组较低的药物成本被住院护理成本的增加所抵消。因此,特拉唑嗪(滴定至最大10mg/天以达到反应)在改善疾病特异性症状和生活质量方面比安慰剂显著更有效,但总体成本与安慰剂相似。另一项同样从美国第三方付款人的角度进行的经济学分析,对中重度BPH男性患者开始治疗后的前2年中与特拉唑嗪、非那雄胺和TURP相关的直接治疗成本进行了建模。研究结果支持特拉唑嗪;接受TURP初级治疗的每位患者的私人保险成本为6411美元,相比之下,非那雄胺为2860美元(TURP成本的45%),特拉唑嗪为2422美元(TURP成本的38%)。所有3个治疗组的医疗保险成本都较低,但相对比较相似;每位患者的相应成本分别为3874美元、2161美元和1820美元(1992年美元)。一项配套的盈亏平衡成本分析使用了一个假设的67岁开始治疗的BPH男性队列。与特拉唑嗪相关的私人保险成本在大约15年内仍低于与TURP相关的成本(非那雄胺与TURP相比的相应盈亏平衡点为10年)。与特拉唑嗪相关的医疗保险成本在大约7年内不会超过TURP的成本(非那雄胺与TURP相比为5.5年)。总之,尽管尚未将特拉唑嗪与其他α1受体拮抗剂进行比较,但迄今为止已对其进行了有限数量的详细药物经济学分析。

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